Unable to Generate PMDA E2B when Study J License field is blank (Doc ID 2237219.1)

Last updated on JUNE 20, 2017

Applies to:

Oracle Argus Safety Japan Cloud Service - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

E2B report for PMDA agency is unable to be generated on a study case when Argus Console >> Business Configuration >> Studies >> J Data Entry >> Products block >> License field is missing/blank.
(When LM_STUDY_PRODUCTS.PRIMARY_PMDA_PRODUCT_LIC_ID is NULL.)

PMDA ICSR Validation Report message:

Missing Mandatory Elements:
J.12.i.1 MHLWINDICATIONFORSTUDY Study Development Phase
J.12.i.2 MHLWPHASEOFSTUDIES Target Disease
J.12.i.1 MHLWINDICATIONFORSTUDY Are any subjects given this investigational drug?

 

 

Cause

Sign In with your My Oracle Support account

Don't have a My Oracle Support account? Click to get started

My Oracle Support provides customers with access to over a
Million Knowledge Articles and hundreds of Community platforms